CHMP

The great news for for our brothers in Europe is that Xtandi (Enzalutamide) has been approved for use in the European Union (EU) for the treatment of men with metastatic castration-resistant prostate cancer whose disease has progressed on or after chemotherapy (docetaxel). Following the regulatory review process by the European Medicines Agency (EMA) and a positive review from the Committee for Medicinal Products for Human Use (CHMP) on 25th April 2013, the European Commission (EC) has granted the marketing authorization for XTANDI (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on [...]

It was announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T) be granted marketing authorization in the European Union (EU), for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. This positive CHMP's recommendation follows a similar positive recommendation by the Committee for Advanced Therapy (CAT). Mark Frohlich, Executive Vice President of Research and Development and Chief Medical Officer of [...]

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted approval of Xtandi in the treatment of men with castrate resistant prostate cancer that has progressed after the use of chemotherapy. It has already been approved for use in the United States. Xtandi (aka Enzalutamide and MDV3100) is a strong androgen receptor inhibitor, some men have likened it to a supercharged Casodex. It blocks androgens from being able to be used by the prostate cancer cells. CHMP is the committee at the European Medicines Agency that is responsible for preparing opinions on questions concerning medicines. The [...]